A phase 3 study of OBE2109 in subjects with heavy menstrual bleeding associated with uterine fibroids.

Phase 1

• Conditions: Treatment of heavy menstrual bleeding associated with uterine fibroids.; MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-004059-53-LT
• Lead Sponsor: ObsEva S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-18
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Premenopausal woman at screening
• Body Mass Index = 18 kg/m2
• Menstrual cycles = 21 days and = 40 days prior to starting screening
• Presence of uterine fibroids
• Heavy menstrual blood loss for the first eight days of two menstrual periods assessed at screening using the alkaline hematin method.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the study
• History of uterus surgery that would interfere with the study
• The subject’s condition is so severe that she will require surgery within 6 months regardless of the treatment provided
• Undiagnosed abnormal uterine bleeding
• Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified